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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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FDA Offers New Guidance on Interpretation of BPCIA

Posted 11 March 2016 | By Zachary Brennan

The US Food and Drug Administration (FDA) on Friday released draft guidance on its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010.

Put simply: FDA will not approve any pending or tentatively approved application for a biological product under the Federal Food, Drug, and Cosmetic (FD&C) Act after 23 March 2020.

The provision in the BPCIA states that: "An approved application for a biological product under section 505 of the Federal Food, Drug, and Cosmetic Act [FD&C] (21 U.S.C. 355) shall be deemed to be a license for the biological product under such section 351 [of the Public Health Service Act (PHS)] on the date that is 10 years after the date of enactment of [the BPCIA]."

FDA interprets this provision to mean that on 23 March 2020, applications for biologics that have been approved under section 505 of the FD&C Act will no longer exist as New Drug Applications (NDAs) (or, as applicable, Abbreviated New Drug Applications (ANDAs)) and will be replaced by approved Biologics License Applications (BLAs) under section 351(a) or 351(k) of the PHS Act, as appropriate.

Rob Cerwinski, a partner in Goodwin Procter's IP Litigation Group, told Focus that with the guidance, FDA wanted to get ahead of companies that might be investing in a decision to file under an NDA or 505(b)2 or ANDA pathway that FDA has typically allowed.

"It's slowing down the process for follow-on biologics where they're simple enough that they wouldn't have to go through the biosimilar pathway," he said.

The approval of new insulins is an example where the approval pathway would be slowed. In December, FDA approved Eli Lilly's Basaglar as a follow-on insulin glargine injection to treat diabetes via a 505(b)2 application that relied partly on the application for Sanofi's Lantus. However, as the FDA notes, "no insulin glargine products are currently licensed under the Public Health Service Act, so there is no 'reference product' for a proposed biosimilar product."

FDA says it recognizes that this interpretation of the legislation could have a significant impact on development programs for any proposed protein products intended for submission under section 505 of the FD&C Act that are not able to receive final approval by 23 March 2020. It also provides recommendations on what to do for such sponsors in the draft guidance.

Although the majority of therapeutic biologics have historically been licensed under the Public Health Service (PHS) Act, FDA says, "Some protein products (e.g., insulin and insulin analogs, human growth hormone, pancreatic enzymes, follitropin products) historically have been approved under the FD&C Act. The BPCI Act changed the statutory authority under which these protein products will be regulated by amending the statutory definition of a 'biological product' in the PHS Act to include a 'protein (except any chemically synthesized polypeptide).'"

Interpretation on Exclusivity

More specifically, FDA said that it interprets this section of the BPCIA and section 351(k)(7) of the PHS Act "to mean that an approved application for a biological product under section 505 of the FD&C Act that will be deemed to be a license for the biological product under section 351(a) of the PHS Act on March 23, 2020, will not have been 'first licensed under subsection (a)' for purposes of section 351(k)(7) of the PHS Act, and thus will not receive a period of exclusivity under section 351(k)(7)(A) and (B) of the PHS Act."

Biologics otherwise enjoy a 12-year exclusivity period during which FDA may not approve a biosimilar's 351(k) application and a 4-year exclusivity period during which an applicant may not submit a 351(k) application that begin on "the date on which the reference product was first licensed under subsection (a) [referring to 210 section 351(a) of the PHS Act]."

Cerwinski said the guidance will not grant 12 years exclusivity just because of the transition of some products.

"Nothing in the BPCI Act suggests that Congress intended to grant biological products approved under section 505 of the FD&C Act — some of which were approved decades ago — a period of exclusivity upon being deemed to have a license under the PHS Act that would impede biosimilar or interchangeable product competition in several product classes until the year 2032," FDA said.

"Companies that made the choice to file NDAs rather than BLAs understood the exclusivity, those expectations haven't been altered," he said.

Sponsors of development programs for proposed protein products should evaluate whether a planned submission under section 505 of the FD&C Act would allow adequate time for approval of the NDA (or, as applicable, ANDA) prior to 23 March 2020, FDA adds, and companies should consider whether the submission may require a second cycle of review and, for certain types of applications, whether unexpired patents or exclusivity may delay final approval.

FDA also discusses what sponsors of proposed protein products intended for submission in a 505(b)(2) application should expect.

Sponsors with product-specific questions should contact the relevant review division within the Office of New Drugs in FDA's CDER regarding the development of a biological product intended for submission in a marketing application under the FD&C Act (during the transition period ending on 23 March 2020) or under section 351(a) or 351(k) of the PHS Act, as appropriate.